The high court, which was dealing with the issue of Sputnik V vaccine, also said going by the rule book to save human lives in these extraordinary times may be in jeopardy and “one has to look at the bigger picture”.
“At this moment, flexibility and alacrity has to be the mantra,” and that the officers should not be afraid of audits and investigations and any officer who refused to act in the current pandemic may open himself to being charged for offences against human body, it said.
These observations were made by the high court in the order on the issue related to manufacturing of COVID vaccine Sputnik V by India’s Panacea Biotec in collaboration with Russian Direct Investment Fund (RDIF).
While taking note of the fact that there have been a large number of coronavirus cases in India, a bench of Justices Manmohan and Najmi Waziri also expressed displeasure that “there is nothing to show that the government officers had handheld the Indian manufacturers of vaccine and acted as facilitators for use of this untapped infrastructure in India”.
“Today, we are a bit anguished with the way things have transpired during the second wave. As a responsible citizen you also would be anguished. Vaccine shortage is hitting each and everyone. Even today vaccine is not available in Delhi… You have good products in India, a little handholding will work,” the bench said.
It added that someone from Russia has been able to locate infrastructure in Himachal Pradesh but the Centre has failed to do so.
Coming on the issue of Sputnik V vaccine, the high court directed the Centre to release arbitral award of over Rs 14 crore along with interest from 2012 to Panacea Biotec for manufacturing Sputnik V vaccine in India subject to the condition that the company obtains permission from the government to manufacture the vaccine.
The bench said the release of the amount, awarded to the company by the arbitral tribunal, will also be subject to the undertaking of the firm that 20 per cent of its sale proceeds of Sputnik V will be deposited with the court’s registry till the awarded amount is secured.
The high court’s order came on a plea of Delhi-based Panacea Biotec seeking to modify a July 2020 order, by which the firm had undertaken not to prosecute further the execution proceedings instituted by them in relation to an arbitral award, running into crores of rupees, passed in its favour and against the Centre.
The company, in its fresh application, sought release of the arbitral award saying it needs funds at the earliest in the larger interest of humanity as it has already manufactured trial batches of COVID vaccine Sputnik V in collaboration with RDIF and the process of manufacturing scale-up batches is on.
At the outset of the hearing, Solicitor General Tushar Mehta said the Prime Minister was one on one talking to other states and even the external affairs ministers was in touch with other countries for arranging vaccines and that the situation is being monitored at the highest level.
The bench said in the absence of any documentary proof by the government and the specific denial by the company that it has not been entirely funded by RDIF, the court cannot presume that the firm is provided with fund by RDIF to facilitate manufacture of Sputnik V in India.
The court made it clear that in this case it was not examining the government policy on procurement and distribution of COVID-19 vaccines.
It also took note that the Delhi government has been repeatedly making statements about shortage of vaccines at its centres, halting its vaccination drive.
The court said from the company’s plea, it was apparent that there is a lot of untapped capacity by way of infrastructure for manufacture of the vaccine in the country.
“However, there is nothing to show that the government officers had handheld the Indian manufacturers of vaccine and acted as facilitators for use of this untapped infrastructure in India. Even when a foreign fund is tapped into this untapped infrastructure to manufacture these vaccines, the officers despite being asked in advance have refused to ensure that the vaccines sought to be manufactured are made available for immediate use in India,” the bench said.
The court said prima facie there was no justification for insisting bridge trials for domestic manufacture of a vaccine but not for the one manufactured abroad.
The court also asked the Central government to consider Panacea’s application seeking waiver of trial for Sputnik V which has already been approved for limited use, in accordance with the law.
Additional Solicitor General Balbir Singh along with Central government standing counsel Rajesh Ranjan said clinical trials have not been waived off anywhere in the world, including India, but it has only been shortened from 10 -12 months to 8-10 weeks.
Senior advocate Sandeep Sethi, representing Panacea Biotec, has said it has only got an advance amount from RDIF and it needs further funds to ramp up its production which has to be 100 million (10 crore) doses per year.